Difference between revisions of "Crizotinib (Xalkori)"

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==General information==
 
==General information==
−
Class/mechanism: Tyrosine kinase inhibitor; inhibits anaplastic lymphoma kinase (ALK), c-MET and subsequent expression of Hepatocyte Growth Factor Receptor (HGFR), and Recepteur d’Origine Nantais (RON). Inhibits activity of fusion proteins involving ALK, such as EML4-ALK and NPM-ALK.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?id=676 Crizotinib (Xalkori) package insert]</ref><ref>[[Media:Crizotinib.pdf | Crizotinib (Xalkori) package insert (locally hosted backup)]]</ref>
+
Class/mechanism: Tyrosine kinase inhibitor; inhibits anaplastic lymphoma kinase (ALK), c-MET and subsequent expression of Hepatocyte Growth Factor Receptor (HGFR), and Recepteur d’Origine Nantais (RON). Inhibits activity of fusion proteins involving ALK, such as EML4-ALK and NPM-ALK.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?id=676 Crizotinib (Xalkori) package insert]</ref><ref>[[:File:Crizotinib.pdf | Crizotinib (Xalkori) package insert (locally hosted backup)]]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
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==Diseases for which it is used==
 
==Diseases for which it is used==
 +
*[[Anaplastic large cell lymphoma, pediatric]]
 
*[[Non-small_cell_lung_cancer,_ALK-positive|ALK+ non-small cell lung cancer]]
 
*[[Non-small_cell_lung_cancer,_ALK-positive|ALK+ non-small cell lung cancer]]
 
*[[Non-small_cell_lung_cancer,_ROS1-positive|ROS1+ non-small cell lung cancer]]
 
*[[Non-small_cell_lung_cancer,_ROS1-positive|ROS1+ non-small cell lung cancer]]
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==Patient drug information==
 
==Patient drug information==
 
*[http://labeling.pfizer.com/showlabeling.aspx?id=676#page=15 Crizotinib (Xalkori) package insert pages 15-18]<ref name="insert"></ref>
 
*[http://labeling.pfizer.com/showlabeling.aspx?id=676#page=15 Crizotinib (Xalkori) package insert pages 15-18]<ref name="insert"></ref>
−
*[http://chemocare.com/chemotherapy/drug-info/crizotinib.aspx Crizotinib (Xalkori) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/crizotinib.aspx Crizotinib (Xalkori) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/crizotinib.aspx Crizotinib (Xalkori) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/crizotinib.aspx Crizotinib (Xalkori) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/crizotinib-patient-drug-information Crizotinib (Xalkori) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/crizotinib-patient-drug-information Crizotinib (Xalkori) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/crizotinib-patient-drug-information Crizotinib (Xalkori) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/crizotinib-patient-drug-information Crizotinib (Xalkori) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
−
*8/26/2011: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269856.htm Initial accelerated approval] for the treatment of patients with locally advanced or metastatic [[Non-small_cell_lung_cancer | non-small cell lung cancer (NSCLC)]] that is [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] as detected by an FDA-approved test.
+
 
−
*11/20/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.htm FDA approval revised] for the treatment of patients with metastatic [[Non-small_cell_lung_cancer | non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]] as detected by an FDA-approved test.
+
===[[Anaplastic large cell lymphoma, pediatric]]===
−
*3/11/2016: FDA approval [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm490391.htm expanded] for the treatment of patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ROS1|ROS1]]-[[Biomarkers#Rearrangement|positive]].
+
*2021-01-14: Approved for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic [[Anaplastic large cell lymphoma, pediatric|anaplastic large cell lymphoma (ALCL)]] that is [[Biomarkers#ALK|ALK]]-[[Biomarkers#Rearrangement|positive]]. ''(New disease entity; based on COG ADVL0912)''
 +
 
 +
===[[Inflammatory myofibroblastic tumor]]===
 +
*2022-07-14: Approved for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive [[Inflammatory myofibroblastic tumor|myofibroblastic tumors (IMT)]]. ''(New disease entity; based on COG ADVL0912 & PROFILE 1013)''
 +
 
 +
===[[Non-small cell lung cancer]]===
 +
*2011-08-26: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm269856.htm Initial accelerated approval] for the treatment of patients with locally advanced or metastatic [[Non-small_cell_lung_cancer | non-small cell lung cancer (NSCLC)]] that is [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]]. ''(Based on PROFILE 1001 ALK)''
 +
**2013-11-20: Converted to full approval for the treatment of patients with metastatic [[Non-small_cell_lung_cancer | non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ALK|anaplastic lymphoma kinase (ALK)]]-[[Biomarkers#Rearrangement|positive]]. ''(Indication removed from locally advanced setting; based on PROFILE 1005, PROFILE 1007, PROFILE 1014)''
 +
*2016-03-11: Approved for the treatment of patients with metastatic [[Non-small_cell_lung_cancer|non-small cell lung cancer (NSCLC)]] whose tumors are [[Biomarkers#ROS1|ROS1]]-[[Biomarkers#Rearrangement|positive]]. ''(New mutation-specific indication; based on PROFILE 1001 ROS1)''
 +
 
 +
==History of changes in EMA indication==
 +
*2012-10-23: Initial marketing authorization as Xalkori.
 +
==History of changes in Health Canada indication==
 +
*2012-04-25: Initial notice of compliance with conditions as monotherapy for use in patients with ALK-positive advanced (not amenable to curative therapy) or metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]].
 +
**2015-11-18: Conditions were met
 +
*2017-08-28: New indication for patients with ROS-1 positive advanced [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]].
 +
==History of changes in PMDA indication==
 +
*2012-03-30: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive [[non-small cell lung cancer]].
 +
*2017-05-18: New additional indication for the treatment of unresectable advanced/relapsed ROS1 fusion gene-positive [[non-small cell lung cancer]].
  
 
==Also known as==
 
==Also known as==
−
*'''Code names:''' PF02341066, PF-02341066
+
*'''Code names:''' PF-02341066
−
*'''Brand name:''' Xalkori
+
*'''Brand name:''' Crizalk, Crizocap, Crizonix, Xalkori
  
 
==References==
 
==References==
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[[Category:Oral medications]]
 
[[Category:Oral medications]]
 
[[Category:Mutation-specific medications]]
 
[[Category:Mutation-specific medications]]
−
 
  
 
[[Category:ALK inhibitors]]
 
[[Category:ALK inhibitors]]
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[[Category:ROS1 inhibitors]]
 
[[Category:ROS1 inhibitors]]
  
 +
[[Category:Anaplastic large cell lymphoma, pediatric medications]]
 +
[[Category:Inflammatory myofibroblastic tumor medications]]
 
[[Category:Non-small cell lung cancer medications]]
 
[[Category:Non-small cell lung cancer medications]]
  
 +
[[Category:EMA approved in 2012]]
 
[[Category:FDA approved in 2011]]
 
[[Category:FDA approved in 2011]]
 +
[[Category:Health Canada approved in 2012]]
 +
[[Category:PMDA approved in 2012]]

Revision as of 23:51, 2 September 2023

General information

Class/mechanism: Tyrosine kinase inhibitor; inhibits anaplastic lymphoma kinase (ALK), c-MET and subsequent expression of Hepatocyte Growth Factor Receptor (HGFR), and Recepteur d’Origine Nantais (RON). Inhibits activity of fusion proteins involving ALK, such as EML4-ALK and NPM-ALK.[1][2]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Anaplastic large cell lymphoma, pediatric

Inflammatory myofibroblastic tumor

  • 2022-07-14: Approved for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). (New disease entity; based on COG ADVL0912 & PROFILE 1013)

Non-small cell lung cancer

History of changes in EMA indication

  • 2012-10-23: Initial marketing authorization as Xalkori.

History of changes in Health Canada indication

  • 2012-04-25: Initial notice of compliance with conditions as monotherapy for use in patients with ALK-positive advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).
    • 2015-11-18: Conditions were met
  • 2017-08-28: New indication for patients with ROS-1 positive advanced non-small cell lung cancer (NSCLC).

History of changes in PMDA indication

  • 2012-03-30: Initial approval for the treatment of unresectable advanced/relapsed ALK fusion gene-positive non-small cell lung cancer.
  • 2017-05-18: New additional indication for the treatment of unresectable advanced/relapsed ROS1 fusion gene-positive non-small cell lung cancer.

Also known as

  • Code names: PF-02341066
  • Brand name: Crizalk, Crizocap, Crizonix, Xalkori

References

  1. ↑ 1.0 1.1 1.2 Crizotinib (Xalkori) package insert
  2. ↑ Crizotinib (Xalkori) package insert (locally hosted backup)
  3. ↑ Crizotinib (Xalkori) patient drug information (Chemocare)
  4. ↑ Crizotinib (Xalkori) patient drug information (UpToDate)
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